BEUDAMED
    FDA Enforcement Class II Terminated

    Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D

    Recall: Z-1965-2019 · Reported July 24, 2019

    Enforcement

    Recall Number
    Z-1965-2019
    Event ID
    83271
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 24, 2019
    Initiation Date
    July 2, 2019
    Classification Date
    July 12, 2019
    Termination Date
    October 5, 2020
    Address
    3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States

    Description

    Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D

    Reason

    Potential for a transducer mis-alignment in certain transvaginal probes.

    Code Info

    Model H48701EJ; Serial Number 205375KR9; (UDI Number) 01008406821085531116071121205375KR9. Model KTZ157043-R Serial Number 152323KR2 (UDI Number Not Available)

    Distribution

    Distribution in the US to Texas. International distribution to France, Greece and Switzerland.

    Quantity

    2 devices